Regulatory Affairs Manager في الأردن

وصف الوظيفة

مدير شؤون تنظيمية في شركة رام للصناعات الدوائية للإشراف على تسجيل وصيانة المنتجات الدوائية وضمان الامتثال للمتطلبات التنظيمية. تتطلب خبرة متقدمة، مع Bachelor's degree in Pharmacy، Proven 10 years’ experience in Regulatory Affairs within the pharmaceutical industry، Preferably 5 years in a managerial role. للتقديم يرجى إرسال السيرة الذاتية إلى البريد الإلكتروني المذكور.

المهام والمسؤوليات

• Lead and manage the Regulatory Affairs activities and ensure compliance with applicable regulatory requirements.
• Manage the registration, renewal, variation, and maintenance of pharmaceutical products with relevant regulatory authorities.
• Prepare, review, and submit regulatory dossiers and required documentation.
• Follow up on regulatory submissions and respond to queries and requirements from regulatory authorities.
• Ensure timely submission and approval of new products, renewals, and variations.
• Monitor changes in regulatory guidelines and requirements and assess their impact on the company's products.
• Coordinate with internal departments, including Quality Assurance, Medical, Production, Supply Chain, and R&D, to ensure regulatory compliance.
• Manage and develop the Regulatory Affairs team and ensure effective workflow and timely completion of assigned activities.

المتطلبات

• Bachelor's degree in Pharmacy
• Proven 10 years’ experience in Regulatory Affairs within the pharmaceutical industry
• Preferably 5 years in a managerial role
• Strong knowledge of pharmaceutical registration requirements and regulatory procedures
• Excellent communication, organizational, analytical, and problem-solving skills
• Strong ability to manage multiple priorities and meet deadlines
• Good command of English, both written and spoken
• Strong leadership and team-management skills

تعليمات التقديم

التعليقات

لا توجد تعليقات منشورة حتى الآن.